By Adriano Marchese
BridgeBio Pharma shares jumped in premarket trading Monday after it received regulatory approval in the U.S. for its treatment for patients with transthyretin amyloid cardiomyopathy.
Shares traded over 25% higher ahead of the morning bell at $29.35.
The Palo Alto, California-based biopharmaceutical company said the Food and Drug Administration approved Attruby for adults with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular death and cardiovascular-related hospitalization.
ATTR-CM affects the heart by depositing clumps of protein in the heart tissue which can affect the heart's ability to function properly and could lead to heart failure.
The FDA approved the treatment based on positive results seen in the its phase-3 study that showed Attruby significantly reduced death and cardiovascular-related hospitalization.
Additionally, BridgeBio said it submitted a marketing authorization application for the drug to the European Medicines Agency, and expects a decision sometime next year. The company has granted exclusive rights to Bayer to commercialize the drug for ATTR-CM in Europe.
Write to Adriano Marchese at adriano.marchese@wsj.com
(END) Dow Jones Newswires
November 25, 2024 09:10 ET (14:10 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
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